Author(s):
Amit Chaudhary, Bhuvnesh Kumar Singh
Email(s):
bhuvneshiftm@gmail.com
DOI:
10.52711/0974-360X.2022.00791 
Address:
Amit Chaudhary1, Bhuvnesh Kumar Singh1,2*
1School of Pharmacy, Abhilashi University, Mandi, Himachal Pradesh, India.
2Teerthanker Mahaveer University, Moradabad, Uttar Pradesh, India.
*Corresponding Author
Published In:
Volume - 15,
Issue - 10,
Year - 2022
ABSTRACT:
In this study, a novel technique was developed and validated for the simultaneous estimation of Remogliflozin (REMO) and Metformin (MET) in bulk and formulation. The separation was achieved using ODS, C18 (250mm × 4.6mm, i.d.2.5µm) column with isocratic elution. A mixture of acetonitrile: 20 mM ammonium formate buffer (pH 3.5) at the ratio of (60:40) as mobile phase with a flow rate of 1.0ml min-1 was used for the separation of analytes. The separated effluents were monitored with diode array detector at 243nm. The results showed good linearity over a range of 2.5–25µg ml-1 and 12.5–125µg ml-1 for REMO and MET respectively. Furthermore, the average percentage assay of marketed formulations of REMO and MET was found to be 100.30% and 100.52%, respectively. REMO limit of detection (LOD) and limit of quantitation (LOQ) were 0.42 and 1.28µg ml-1 while LOD and LOQ for MET were 1.97 and 5.96µg ml-1 respectively. The proposed method was simple, rapid and precise for the study of new formulations which has been approved for the cure of diabetes mellitus and applicable for the analysis of both drugs in pharmaceutical industries effectively.
Cite this article:
Amit Chaudhary, Bhuvnesh Kumar Singh. Method Development and Validation for simultaneous Quantification of Remogliflozin and Metformin in Bulk and Tablets by RP-HPLC. Research Journal of Pharmacy and Technology 2022; 15(10):4709-4. doi: 10.52711/0974-360X.2022.00791
Cite(Electronic):
Amit Chaudhary, Bhuvnesh Kumar Singh. Method Development and Validation for simultaneous Quantification of Remogliflozin and Metformin in Bulk and Tablets by RP-HPLC. Research Journal of Pharmacy and Technology 2022; 15(10):4709-4. doi: 10.52711/0974-360X.2022.00791 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-10-64
REFERENCES:
1. Mudaliar S, Armstrong DA, Mavian AA, O’Connor-Semmes R, Mydlow PK, Ye J, Hussey EK, Nunez DJ, Henry RR, Dobbins RL. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes. Diabetes Care. 2012 Nov 1;35(11):2198-200. doi: 10.2337/dc12-0508
2. Attimarad M, Elgorashe RE, Subramaniam R, Islam MM, Venugopala KN, Nagaraja S, Balgoname AA. Development and Validation of Rapid RP-HPLC and Green Second-Derivative UV Spectroscopic Methods for Simultaneous Quantification of Metformin and Remogliflozin in Formulation Using Experimental Design. Separations. 2020 Dec;7(4):59. doi: 10.3390/ijerph18020448
3. Tammisetty MO, Challa BR, Puttagunta SB. A novel analytical method for the simultaneous estimation of remogliflozin and metformin hydrochloride by UPLC/PDA in bulk and formulation. Application to the estimation of product traces. Turk. J. Pharm. Sci. 2020 Jun 8;39699.
4. Önal A. Spectrophotometric and HPLC determinations of anti-diabetic drugs, rosiglitazone maleate and metformin hydrochloride, in pure form and in pharmaceutical preparations. European journal of medicinal chemistry. 2009 Dec 1;44(12):4998-5005.doi: 10.1016/j.ejmech.2009.09.003
5. Sushil DP, Sayali KC, Sanjay K. Development and validation of UV spectrophotometric method for Simultaneous estimation of Empagliflozin and Metformin hydrochloride in bulk drugs. Asian J. Pharm. Ana. 2017; 7(2): 117-123.
6. Saroj G, Vedantika D, Ashwini S, Amar Z, Ravindra BS. Development and Validation of Linagliptin and Metformin hydrochloride in Bulk and Combined Tablet Dosage Form by using UV Spectrophotometric Method. Asian J. Pharm. Ana. 2017; 7(2): 141-144.
7. Nachiket SD, Ganesh SS, Vikas BS. Simultaneous Estimation and Validation of Canagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by using RP-HPLC. Research J. Pharm. and Tech. 2019; 12(10):4953-4957.
8. B. Sivagam, A Purushotham, PranabeshSikdar, R. Chandrasekar, M. Niranjan Babu. A Validated Method for The Simultaneous Estimation of Linagliptin and Metformin in Tablet Dosage Forms by RP-HPLC. Research J. Pharm. and Tech 2020; 13(3):1266-1270.
9. Shrikrishna B. Baokar, Sugandha V. Mulgund, Nisharani S. Ranpise. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Vildagliptin and Metformin. Research J. Pharma. Dosage Forms and Tech. 2013; 5(2): 95-98.
10. Nishanth I., Elango K., Deattu N., Stephen P. Formulation Development and Evaluation of Bilayer Tablets of Telmisartan for Immediate Release and Metformin Hydrochloride for Sustained Release. Research J. Pharma. Dosage Forms and Tech. 2013; 5(3): 139-144.
11. Manojkumar K. Munde, Nilesh S. Kulkarni, Rahul H. Khiste, Dhanya B. Sen. Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy. Research J. Pharm. and Tech 2020; 13(3):1236-1242.
12. Khalil GA, Salama I, Gomma MS, Helal MA. Validated RP-HPLC method for simultaneous detrmination of canagliflozin, dapagliflozin,empagliflozin and metformin. Int J Pharm Chem Biol Sci. 2018;8(1):1–13.
13. Gurrala S, Shivaraj CV, Anumolu PD, Saraf G. Analytical Quality by Design Assisted HPLC Method for Quantification of Canagliflozin/Metformin and Stability Studies. Indian Journal of Pharmaceutical Education and Research. 2019 Oct 1;53(4):s699-708.doi:10.5530/ijper.53.4s.167
14. Satheesh KN, Pradeepkumar M, Shanthikumar S, Rao VJ. Development of validated stability indicating assay method for simultaneous estimation of metformin hydrochloride and vildagliptin by RP-HPLC. Drug Res. 2014;64(3):124–9.doi: 10.1055/s-0033-1354373
15. Deepan T, Rao MB, Dhanaraju MD. Development of validated stability indicating assay method for simultaneous estimation of metformin and dapagliflozin by RP-HPLC. European Journal of Applied Sciences. 2017 Jan;9(4):189-99.doi: 10.1055/s-0033-1354373.
16. Gedawy A, Al-Salami H, Dass CR. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide. journal of food and drug analysis. 2019 Jan 1;27(1):315-22.doi: 10.1016/j.jfda.2018.06.007
17. Shabir GA. Development and validation of RP-HPLC method for the determination of methamphetamine and propranolol in tablet dosage form. Indian journal of pharmaceutical sciences. 2011 Jul;73(4):430.doi: 10.4103/0250-474X.95632
18. Kapil R, Pushpendra S. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Science and Technology. 2021; 13(2):111-8.
19. Kapil R, Pushpendra S. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Science and Technology. 2021; 13(2):111-8.Saudagar PGT, RB. A Review - Importance of RP-HPLC in Analytical Method Development. Indo Am J Pharm Sci. 2018;05(05):4897–907.
20. Dave V, Paresh P. Method development and Validation of UV Spectrophotometric estimation of Remogliflozin Etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021; 14(4):2042-4.
21. Prathap B, Dey A, Johnson P, Arthanariswaran P. A review-importance of RP-HPLC in analytical method development. International Journal of Novel Trends in Pharmaceutical Sciences. 2013 Jan 10;3(1):15-23.
22. Tiwari G, Tiwari R. Bioanalytical method validation: An updated review. Pharmaceutical methods. 2010 Oct 1;1(1):25-38.
23. Rao TN. Validation of Analytical Methods. In: Calibration and Validation of Analytical Methods - A Sampling of Current Approaches. InTech; 2018;132–42.
24. ICH Topic Q 2 A Validation of Analytical Methods : Definitions and Terminology Note For Guidance On Validation of Analytical Methods. ICH. 1995. p. 1–5.
25. Guidance for Industry Q2B Validation of Analytical Procedures : Methodology Guidance for Industry Q2B Validation of Analytical Procedures : Methodology. ICH. 1996.
26. Sirigiri N, Subramanian NS, Reddy NK. Stability Indicating Method Development and Validation for Simultaneous Estimation of Sitagliptin Phosphate and Metformin HCL in Tablets by HPLC. Int J Pharm Sci Reserch. 2018 Feb ;9(10):4294–302.
27. Swamy GK, Lalitha R, Mounika C, Soumya B, Kumar DS. A Validated RP-HPLC Method for Simultanious Determination of Metformin and Canagliflozin in Pharmaceutical Formulation. Asian Journal of Pharmaceutical Analysis. 2018 Jun 11;8(2):73-7.doi:10.5958/0974-360X.2020.00320.0